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crystalline forms

May 08, 2009

Israel has both pre-grant patent oppositions as well as post-grant revocation proceedings.Sometimes the PTO’s decisions in these proceedings make sense.Sometimes they don’t.A recent opposition decision, Unipharm v SmithKline Beecham (opposition to patent application no. 117035) falls squarely into the latter category.In fact, it’s so egregiously bad it’s going to provide fodder for several posts.I will leave a full discussion of the facts, and my criticisms of the PTO’s reasoning (or lack thereof) for another day.

Today I provide a brief synopsis of the facts and two practical implications for practice before the Israel PTO.For those who don’t have time or patience to read all the way through even this brief presentation, the practical implications are as follows:

(1)

If you have a particularly valuable application pending in Israel that has claims to different types of statutory subject matter, you should consider dividing the application, even if the ILPTO doesn’t tell you to do so.This is because if the application is opposed, and claims directed to one class are found to be unallowable, the claims to the other class(es) may go down as well, solely on the grounds that they are grouped with the unallowable claims.

(2)

When citing your own earlier application as prior art to the Israel PTO, be sure to cite all the priority applications for that earlier application, unless you’re sure your earlier application contains all the statements that appeared in the priority application.Failure to do so can be deemed to be the Israel equivalent of inequitable conduct.

In a decision given April 16, 2009, the Deputy Commissioner (DC) sustained an opposition to an SKB application that claimed crystalline paroxetine hydrochloride anhydrate (PHA) and a method for making this material.The DC ruled that the material per se was not novel, because SKB had earlier produced the material.SKB had argued that since the (published) method by which the material had originally been made stopped working a few years later, and at the time the subject application was filed, that known method yielded the hemi-hydrate, not the anhydrate, there was no enabling description in the prior art at the time the subject application was filed.Therefore, said SKB, the anhydrate per se was novel at the time the application was filed.The DC rejected this argument and said that the crystalline anhydrate per se existed, and therefore the claims on this material were anticipated.

There were two unfortunate parts of the decision.The first was that although the DC acknowledged that the newly-claimed process for making the anhydrate was novel and non-obvious (it took several years for SKB to develop the new process, and the process itself involved crystallizing the anhydrous material from an aqueous solution!), he nevertheless refused to allow the method claims, saying that since they were grouped in the same application as the unallowable crystalline form claims, the method claims too had to fall - even though he could have exercised his discretion and allowed the method claims, or ordered their division from the unallowable crystalline form claims.

The second unfortunate part was the DC’s determination that the entire application should also be rejected for failure to disclose prior art.This part of the decision stemmed from the fact that although SKB mentioned in the application itself the earlier patent, EP 223403B1, which disclosed PHA, SKB did not disclose the existence of an earlier British application from which the ‘403 patent claimed priority.As will be discussed in a later post, there were slight differences between the priority document and the patent, and apparently the DC felt that these differences were sufficient to warrant non-issuance of the patent – the Israeli equivalent of inequitable conduct in the U.S.A.

This is the first opposition of which I am aware in which the ILPTO refused otherwise allowable claims on the grounds that they were grouped with unallowable claims.Had GSK divided the application and filed the method-of-making claims in a divisional, the DC could not have invoked these grounds for rejecting the claims.And while it is not the first opposition in which an application has been shot down for failure to disclose prior art, it is the first of which I am aware in which the non-disclosed prior art was a priority application for a patent that the applicant did disclose.

It is unclear if this case will remain an isolated instance with regard to the grouping of non-allowable claims with allowable claims, or heralds a new approach from the ILPTO.It could just be an isolated case, as the rejection of the method claims may have been the DC's way of punishing the applicant for attempting to obtain claims on a material that the applicant acknowledged had at one time been known; this particular fact pattern is unlikely to repeat itself, and thus the PTO may be unlikely to invoke suchpunitive measures again.It could also be an isolated instance because this part of the decision may be deemed on appeal to be dictum: since DC also ruled that the entire application was unallowable for failure to disclose prior art, it may be that the DC's statements about the grouping of the claims isn't part of the holding.

If, however, the DC's statements indicate a new approach on the part of the ILPTO (even if in this case are they are deemed to be dicta), this new approach places applicants in a tenuous position: once an application has been accepted (i.e. published for opposition), an applicant may cancel claims from the application, but he cannot expand the scope of the claims and he can no longer file divisionals (although, as mentioned above, the Commissioner can order division during an opposition).Thus applicants in Israel may now be facing the choice of (possibly unnecessarily) dividing the application during ex parte prosecution, or not dividing but then losing otherwise valid claims because the applicants weren't prescient enough to know that some of the other claims wouldbe found invalid during opposition, thus dragging the rest of the application down with them.

Because of this decision, its uncertain impact (GSK still has time to appeal the decision, and it cannot be predicted when a decision will be given in the appeal if filed), and the fact if adopted as policy by the ILPTO, applicants' hands will be tied oncetheir applications are published, it appears that in cases of important applications having claims directed to different statutory classes (composition of matter, method for making, pharmaceutical composition and use), applicants should consider voluntarily dividing the application before acceptance.

As to the failure to disclose the priority document, if the DC’s determination stands, then it would seem incumbent upon applicants, at least when citing their own prior patents or published applications, to also cite the corresponding priority applications.